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DMOE-0, Specialist Biosample Operations
A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Expert 2.1: Specialist Biosample Operations
Your role: an exciting opportunity has arisen to join our healthcare business to support the development of first and best in class specialty medicines for our patients in need. You will work in a group, that provides support for study teams of Phase I - Phase IV (interventional & non-interventional) and Investigator Sponsored Studies. As a Specialist Biosample Operations, you will manage activities within a dedicated Center of Excellence for operational deliverables of Clinical Studies with interactions of multiple cross functional Biopharma functions and CROs.
Your main responsibilities would be:
- Manage set up and maintenance of studies in the Biosample Information database in collaboration with Biosample Operation Lead (BOL) assigned to the clinical study.
- Supports Biosample Operation activities by proof reading site training materials and biosample handling instructions in regard to Biomarker/Biosample operational aspects.
- Review sample inventories and reports provided by central laboratory.
- Perform quality checks on patient consent attribute log files.
- Maintains oversight of sample reconciliation against consent (ICFs) and eCRF data by checking report received from clinical CRO.
- Checks that clinical biosample operation, clinical biomarker and PK/ADA relevant documentation(s) are filed in eTMF
- Assist the Biosample Operations Lead and Bioanalytical Operation Manager (BAOM) in preparation of audits and inspections, retrieve documents from CRO.
- Supports Bioanalytical Operations Manager in managing invoice processing & tracking (incl. Purchase Order, Payment Tracking & Reporting) for bioanalytical vendors.
- Manage Document Management System (Veeva Vault). Uploads & approval flows for bioanalytical reports.
- Track bioanalytical lab performance (KPI, timelines).
- Support production of critical reagents, organize shipment to CRO and maintain inventory.
- Supports study closure activities related to Biosample disposal / relocation to biorepository.
- Maintains and continually updates knowledge of applicable Policies, Quality Documents, conventions, tools, templates, instructions, Good Clinical Practice (ICH-GCP), applicable national regulation and ensures implementation for the conduct of the tasks.
- Communicate knowledge and lessons learned from trial within the organization, support development and dissemination of best practices in trial management.
Who You Are:
- 4+ years clinical operations experiences
- Certification in Clinical Research or Bachelor or master's degree in clinical research/Clinical Trial Management is preferred
- Requires operational experience in relevant disciplines and project management experience. Requires knowledge and experience in own discipline.
- Excellent command of English language (verbally and in writing)
- Proven experience in working in an international/ multicultural cross functional matrix environment.
- Good understanding of the policies and procedures of Clinical Operations and of ICH-GCP
- Attention to details, analytical thinker & problem solver.
- Good administrative, coordination and problem- solving skills.
- Good time and priority management, ability to work efficiently under pressure.
- Strong computer skills including knowledge of MS Office™ (Excel™, Word™, PowerPoint™), Outlook and Teams
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!